The National Heart, Lung, and Blood Institute (NHLBI) and National
Institute of Neurological Disorders and Stroke (NINDS) invite research grant
applications focusing on effective interventions that will provide sound
scientific evidence for expanding sustainable blood pressure prevention and
control programs in low and middle income countries (LMICs) at the local,
regional, and national level.

Key Dates

Posted Date

June 2, 2011

Open Date (Earliest Submission Date)

July 10, 2011

Letter of Intent Due Date

July 10, 2011

Application Due Date(s)

August 10, 2011, by 5:00 PM local time of applicant
organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November 2011

Advisory Council Review

January 2012

Earliest Start Date(s)

April 1, 2012

Expiration Date

August 11, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the SF
424 (R&R) Application Guide except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any program-specific
instructions noted in Section IV. When
the program-specific instructions deviate from those in the Application Guide,
follow the program-specific instructions. Applications that do not
comply with these instructions may be delayed or not accepted for review.

The National Heart, Lung, and Blood Institute (NHLBI) and National
Institute of Neurological Disorders and Stroke (NINDS) invite research grant
applications focusing on effective interventions that will provide sound
scientific evidence for expanding sustainable blood pressure prevention and
control programs in low and middle income countries (LMICs) (See http://data.worldbank.org/about/country-classifications for LMIC definitions) at the local, regional and national level.

This FOA is being issued in cooperation with the Global
Alliance for Chronic Diseases (GACD) (http://www.ga-cd.org/).
Members of the GACD include the Medical Research Councils of the United Kingdom
and South Africa; The Australian Health and Medical Research Council (NHMRC);
the Canadian Institutes of Health Research (CIHR); the National Heart, Lung,
and Blood Institute (NHLBI) of the National Institutes of Health in the United
States; and the Chinese Academy of Medical Sciences. Each member will issue
their own solicitation, but funded projects will be part of a Consortium.

The following Principles of the GACD are reflected in this
FOA: 1) A commitment to improving health gains while reducing health
disparities in LMICs and among Aboriginal populations in higher income
countries; 2) A focus on research topics where the need for evidence to inform
policy, programs, and practice is most urgent; 3) The translation of research
findings and the exchange of (clinical) approaches that are designed to
maximize public health benefits; 4) The identification of common approaches for
the implementation, integration, and scaling-up of health service delivery
systems.

Learning from individual projects is expected to provide
evidence that will support local decision making. Cumulative learning across
funded projects is expected to provide a basis for evidence-informed
recommendations for national and international organizations.

Outcomes expected from this FOA across participating
countries include: 1) Established networks of teams involved in implementation
research for chronic disease prevention and management; 2) Advances in the
field of implementation science with applicability to other settings and other
health issues; 3) Common protocols for implementation science initiatives
developed and refined, including protocols for systems analysis; and 4)
Strengthened capacity for implementation research in chronic disease.

The long term goal is for the results of projects supported
by this announcement to provide healthcare providers and decision-makers with
the scientific evidence to implement effective programs that will: 1) reduce
the prevalence of cardiovascular disease (heart disease and stroke) developing
as a consequence of high blood pressure and 2) inform implementation and enable
scale-up of larger programs (including related policies in health and other
sectors) at local, national and regional levels.

This NHLBI FOA is calling for applications from US domestic
institutions, in partnership with one or more institutions in a LMIC, where the
majority of the implementation work is being conducted in the LMIC.

Background

Hypertension is a major contributor to the growing global
pandemic of cardiovascular disease and stroke. This FOA seeks research projects
which will emphasize implementation science and will focus on hypertension
prevention and control in Low and Middle Income Countries (LMICs) (See http://data.worldbank.org/about/country-classifications for LMIC definitions). Poor control rates for hypertension and a lack of
strategies to maintain normal blood pressure, particularly in LMICs, reflect
the challenges of effective and affordable implementation in health care and
other systems. This program seeks to improve the implementation of existing
approaches to prevention and control rather than to develop new treatments. Developing
novel and effective means of controlling blood pressure in persons who have
suffered stroke or transient ischemic attack is of particular interest to NINDS.

The GACD Members will encourage research from a variety of
settings in LMICs. Research involving the active engagement of Aboriginal
communities in Canada and Australia will also be considered by CIHR and NHMRC
respectively, but not by NHLBI.

The overall aims of this program are: 1) to develop a better
understanding of key barriers and facilitators at local and national levels that
affect hypertension control and to consider how these implementation challenges
can be overcome; 2) to understand how innovations for hypertension control can
be introduced and scaled-up across a range of settings; 3) to identify what
elements of systems most need to be strengthened to prevent hypertension and
its consequences (e.g., stroke); and 4) to improve hypertension control rates
while reducing disparities in hypertension control across population
sub-groups.

This FOA is designed to optimize cumulative learning across
individual projects, and to ensure that results are interpretable and can be
generalized across locations. These include standard metrics and/or protocols
for examining outcomes and for assessing features of the health care system and
the broader context. The development of these standard metrics and/or
protocols will be undertaken in consultation with national and international
investigators, decision-makers, and policy-makers. Funded teams will come
together as a consortium to develop approaches to standardize data collection
and are expected to use these standardized approaches in their respective
projects. This will allow the sharing of outcome data across projects. A scientific
standards and data-sharing technical advisory group will be established for
this program by the GACD consortium.

There are expected to be important differences across the
settings of funded study teams. These differences include variations in:
social, economic and cultural contexts; population health disparities and
disease burdens; health care delivery models including the mix of formal and
informal health care providers; financing models for chronic disease prevention
and control; private and non-governmental organization (NGO) sector engagement
in chronic disease; and regulatory structures. These differences will provide
an important basis for programmatic learning about the implementation and
scale-up of hypertension prevention and control programs.

Program
Structure

This FOA is inviting applications from US domestic
institutions where a significant part of the work is conducted in a LMIC,
however, it is required that the applicant institution's Principal investigator
has a substantial involvement in the direction of the research program. This
includes being able to provide appropriate oversight of all scientific,
programmatic, financial, and administrative matters related to the grant.

One of the goals of this FOA is to develop a highly
interactive and synergetic Consortium of Investigators across the world who
will share ideas, data, and resources to improve high blood pressure prevention
and control in LMICs. The Consortium will consist of projects funded through
this FOA and other projects funded through the GACD independent solicitations.
Collaboration and interaction among Consortium investigators will be
requirements of the program and will be facilitated with teleconferences and
meetings of the investigators organized by the GACD. Two investigators per
project (one from the US and one from the partner LMIC) should agree to be
active participants in Consortium-wide activities as deemed necessary by
appropriate oversight committees. Such activities may include development and
standardization of tools such as common data collection instruments and
training materials, among others.

Steering
Committee: The Consortium will have a Steering Committee that
will be responsible for overall scientific direction, coordination, and
oversight. The Steering Committee will be composed of two investigators per
project (one from the US and one from the partner LMIC), and the NHLBI Project
scientist. The role of the NHLBI Project scientist is described under
Cooperative Agreement Terms and Conditions of Award Section V1.2. The Steering
Committee will meet in person for an implementation meeting at the start of the
project period, by conference call at least quarterly, and in person once a
year in a LMIC throughout the project period (Annual Grantees meeting- see
below). Participation in Steering Committee Activities is a requirement for the
two investigators of each project (one from the US and one from the partner
LMIC). Funds should be requested in the application's budget to attend Steering
Committee meetings.

Annual
Grantee Meeting: The GACD will arrange annual meetings to
encourage the exchange of information for the Consortium and potentially with
other stakeholders. In the preparation of the budget for the grant application,
applicants should include travel funds for one meeting each year to be held in
a LMIC, for the principal investigator from the US, investigator from the LMIC
partner, key collaborators, and trainees. A major goal of these meetings is to
facilitate progress by providing a forum that will lead to sharing skills,
ideas, technology, and data. At the meetings, participants will discuss
coordination, sharing and a means of informing the community and policy makers
about the progress made by the Consortium.

Research
Applications

Research projects should include a focus on one or more of
the following components that are crucial for the prevention and control of
high blood pressure:

Prevention of high blood pressure by addressing lifestyle and
environmental risk factors (e.g., high salt intake) through multi-strategy and multi-level
initiatives.

Identification of individuals with high blood pressure
(awareness).

Initiation of treatment for individuals with high blood pressure
with proven lifestyle and pharmacological interventions (treatment).

Sustaining treatment and self-care management of high blood
pressure, adding additional interventions until the treatment goals are
achieved control.

Identification of individuals at risk for secondary stroke and
the need for aggressive secondary prevention measures (awareness).

Initiation of treatment that controls blood pressure and other
stroke risk factors for individuals with recent stroke and TIA with proven
lifestyle, diet and pharmacological interventions (treatment).

System barriers to hypertension prevention and/or control and how
these can be addressed.

How decision-makers and other knowledge users will be engaged in
the project. Letter(s) of support from relevant decision-maker(s) should be
included.

An implementation component - implementation should involve some
strategies with demonstrated efficacy and/or effectiveness and may also include
the development of new strategies.

An assessment of equity and gender gaps in blood pressure
prevention and control.

The multidisciplinary composition of research teams.

An appropriate plan for knowledge translation and exchange as a
component of the project. This should include a training and implementation
science capacity-building component.

Programs proposed can be new or linked to existing programs.
Innovative approaches, including those that draw on successful local experience
and those that lend themselves to adaptation to other environments, will
be encouraged through this funding mechanism.

Applications in response to this announcement may utilize a
variety of approaches such as experimental and quasi-experimental study
designs, mixed methods studies, comparative case studies, economic and
mathematical modeling, and combined approaches.

Selected
Examples of innovative approaches include but are not limited to:

1. The use of electronic and
cell phone information and communication technologies.

2. The involvement of
industry and non-governmental organizations in health or other sectors.

3. The participation of
community workers and community leaders.

4. The use of electronic and cell phone information and
communication technologies to monitor adherence and control of blood pressure
in survivors of recent stroke or TIA.

5. The development of low cost and
sustainable tools such as check lists for persons who have survived stroke and
TIA as well as providers.

6. The integration of
community workers and community leaders in controlling blood pressure for
stroke and TIA survivors.

Selected Research Examples include but are not limited
to:

1. Implementation of an
intervention program targeting environmental supports and policies that make
healthy eating and a lower sodium diet an easier choice. This might include:

Measures the success of the program in terms of reducing the rate
of recurrent stroke, compliance, and control of blood pressure.

Examines the sustainability of the program and adapts its scope
to the resources anticipated in the longer term.

Section
II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there
will be substantial Federal scientific or programmatic involvement.
Substantial involvement means that, after award, scientific or program staff
will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER
Glossary and the SF 424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH
appropriations, and the submission of a sufficient number of meritorious
applications.

NHLBI intends to fund 2-3 awards.

NHLBI intends to commit a total of $1M for fiscal year 2012.

NHLBI intends to commit a total of $2M for each of fiscal
years 2013, 2014, and 2015

NHLBI intends to commit a total of $1.5M for fiscal year
2016

NINDS has assigned funds to support one project focused on
the prevention of secondary stroke, contingent upon the availability of funds
and the receipt of a sufficient number of meritorious applications proposing
projects relevant to the programmatic priorities of the NINDS. Direct costs
are limited to $230,000 in year 1, to $450,000 in years 2-4, and to $250,000
in year 5 of the project period.

Award Budget

Direct costs are limited to $230,000 in year 1, to
$450,000 in years 2-4, and to $250,000 in year 5 of the project period. Applicants
must submit non-modular budgets using the non-modular format. Direct
Costs for the domestic component are limited to 30% of the total direct costs
per year.

Award Project Period

Five years

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions:

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Organizations) are
not eligible to apply.
Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the
following registrations.

All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept or award any application in response to
this FOA that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed.

Eligible studies

High priority will be given
to work in non-GACD member low and middle income countries. For the purpose of
this solicitation, a GACD member is defined as a public funder of research
in a country that has committed or communicated to the leadership of the GACD
its intention to join the GACD.

Given the implementation focus of this FOA, the following
types of studies will be considered non-responsive:

Replication effectiveness studies.

Clinical trials testing the efficacy or effectiveness of new or
established pharmacological agents (or combination of agents) which have wider
effects than those relating to hypertension alone.

An application that is essentially the same as one submitted to
any other solicitation associated with this program issued by the GACD members.
Solicitations by GACD FOA participating members (UK-MRC, NH-MRC and CIHR) will
be issued in April 2011 under the titles of "Reducing the Impact of
Hypertension in Low and Middle Income Countries" for UK-MRC and "Reducing
the Impact of Hypertension in Low and Middle Income Countries and Aboriginal
Populations” for CIHR and NHMRC.

Section
IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and
Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Letter of Intent

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel in US and LMIC institutions
Participating institutions
Number and title of this funding opportunity

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
application submission. Follow all instructions in the SF424 (R&R)
Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modifications:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Appendix

Do not use the appendix to circumvent page limits.
Follow all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

Foreign Organizations

Foreign (non-US) organizations must follow policies
described in the NIH Grants
Policy Statement, and procedures for foreign organizations described
throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application in the eRA Commons to ensure
accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD/PIs must include their eRA Commons ID in the Credential
fieldof the Senior/Key Person Profile Component of the SF 424(R&R)
Application Package. Failure to register in the Commons and to include a
valid PD/PI Commons ID in the credential field will prevent the successful
submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by components of participating organizations NIH. Applications that are incomplete and/or nonresponsive will not be
reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section
V. Application Review Information

1. Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following review criteria and additional review criteria
(as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers
well suited to the project? If Early Stage Investigators or New Investigators,
or in the early stages of independent careers, do they have appropriate
experience and training? If established, have they demonstrated an ongoing
record of accomplishments that have advanced their field(s)? If the project is
collaborative or multi-PD/PI, do the investigators have complementary and
integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Quality of the Team

Does the application demonstrate the active
participation of decision makers? (Letter(s) of support from relevant
decision-maker(s) should be included in the application.)

Implementation Plans

Are the proposed intervention strategies relevant to
the social, cultural and economic context? Have inequities and equity gaps,
including gender, been taken into account in the design of the proposed
implementation strategy?

Have objective measures of evaluation of the
effectiveness of hypertension prevention and control been included? Does the application
include consideration of the potential for scaling-up intervention strategies
in the local environment, such as addressing affordability for users, financial
implications for implementing organizations and funders, etc? Does the
application propose a training and implementation science capacity-building
component?

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider
each of the following items, but will not give scores for these items, and
should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Applications
from Foreign organizations will not be accepted for this FOA.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall
impact/priority score.

Will receive a written critique.

Applications will be assigned on the basis of established
PHS referral guidelines to the NHLBI or NINDS. Applications will compete for
available funds with all other recommended applications submitted in response
to this FOA. Following initial peer review, recommended applications will
receive a second level of review by the NHLBI and NINDS Advisory Councils. The
following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

Geographic distribution

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the
cooperative agreement, an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

All aspects of the study, including any modification of
study design, conduct of the study, quality control, data analysis and
interpretation, preparation of publications, and collaboration with other
investigators, unless otherwise provided for in these terms or by action of the
Steering Committee.

Awardee(s) agree to the governance of the study through a
Steering Committee. Steering Committee voting membership shall consist of the
principal investigators (i.e., cooperative agreement awardees), and the
NHLBI Project Scientist. The Steering Committee will meet in person for an
implementation meeting at the start of the project period, by conference call
at least quarterly, and in person once a year in a LMIC throughout the project
period.

Encouraging study investigators to publish and to release
publicly and disseminate results and other products of their study, in
accordance with study protocols and governance. Within three years of the end
of the period of NHLBI support for the project, data not previously released
and other study materials or products not previously distributed are to be made
available to individuals who are not study investigators, provided such release
is consistent with the study protocol and governance. In addition, study
investigators must establish a plan for making data sets and materials available
to the scientific community and to the NHLBI immediately upon completion of the
three year period following the end of the period of NHLBI support.

Ensuring that upon completion of the project, awardees put
their intervention materials and procedure manuals into the public domain
and/or make them available to other investigators, according to the approved
plan for making data and materials available to the scientific community and
the NHLBI, for the conduct of research at no charge other than the costs of
reproduction and distribution.

Asking Awardees to share data and tools with the Consortium
members as resources are being developed when deemed appropriate and discussed
and approved by the Steering Committee. Awardees will retain custody of and have
primary rights to the data and software developed under these awards, subject
to Government rights of access consistent with current DHHS, PHS, and NIH
policies. The NHLBI Project Scientist, on behalf of the NHLBI, will have the
same access, privileges and responsibilities regarding the collaborative data
as the other members of the Steering Committee

NIH staff has substantial programmatic involvement that
is above and beyond the normal stewardship role in awards, as described below:

The NHLBI Project Scientist will serve on the Steering
Committee; he/she or other NHLBI scientists may serve on other study
committees, when appropriate. The NHLBI Project Scientist (and other NHLBI
scientists) may work with awardees on issues coming before the Steering Committee
and, as appropriate, other committees, e.g., data sharing and database
development, quality control, adherence to protocol, core establishment.

The NHLBI reserves the right to withhold funding or curtail
the study (or an individual award) in the event of (a) substantive changes in
the agreed-upon work scope with which NHLBI cannot concur, (b) human subject
ethical issues that may dictate a premature termination.

Support or other involvement of industry or any other third
party in the study -- e.g., participation by the third party; involvement of
study resources or citing the name of the study or NHLBI support; or special
access to study results, data, findings or resources -- may be advantageous and
appropriate. However, except for licensing of patents or copyrights, support or
involvement of any third party will occur only following notification of and
concurrence by NHLBI.

Additionally, an agency program official or NIH program
director will be responsible for the normal scientific and programmatic
stewardship of the award and will be named in the award notice. The assigned
program director may also serve as an NIH Project Scientist.

Areas of Joint Responsibility include:

Awardees agree to the governance of the Consortium through
the Steering Committee. The Steering Committee Chair will be appointed by
NHLBI. Additional members may be added by majority vote of the Steering
Committee.

Awardee members of the Steering Committee agree to accept
and implement policies approved by the Steering Committee, and recommendations
from the External Advisory Committee if one is constituted.

Dispute Resolution:

Any disagreements that may arise in scientific or
programmatic matters (within the scope of the award) between award recipients
and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel
composed of three members will be convened. It will have three members: a
designee of the Steering Committee chosen without NIH staff voting, one NIH
designee, and a third designee with expertise in the relevant area who is
chosen by the other two; in the case of individual disagreement, the first
member may be chosen by the individual awardee. This special dispute resolution
procedure does not alter the awardee's right to appeal an adverse action that
is otherwise appealable in accordance with PHS regulation 42 CFR Part 50,
Subpart D and DHHS regulation 45 CFR Part 16.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award as described in the NIH Grants Policy
Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.